Multi-billion contract on the line as UK regulator reviews rapid testing device for continued use

A multi-billion contract the government signed with a US-based diagnostic firm could be in jeopardy if Britain’s medicines regulators does not renew its special authorisation of one of the most widely-used rapid home tests in the UK.

The Innova lateral flow test was first approved by the Medicines and Healthcare products Regulatory Agency (MHRA) back in December – but only under a time sensitive Emergency Use Authorisation (EUA) that expires on 22 June.

As part of contracts with the government worth around £3 billion, Innova has supplied more than one billion tests to the UK, which are being used as part of Downing Street’s twice-weekly mass testing programme – a crucial pillar of NHS Test and Trace.

However, the tests have been plagued by controversy. Fears have been raised that the devices are not sensitive enough and may incorrectly inform infected people that they do not have the virus, encouraging them to lower their guard and contribute to onward transmission.

The MHRA also reportedly expressed its concern with the Department of Health and Social Care (DHSC) that the mass testing programme unveiled by the government in April was “a stretch” of its authorisation for how the devices should be used.

It told DHSC in December that “we do not currently support” use of the device as “a ‘test to enable’ function” – in essence, one that would allow people greater freedoms if they returned a negative result.

However, according to the Guardian, the MHRA was worried that Downing Street did not make clear that the devices should only be used as a “red light” test to detect infectious people and order them to isolate.

Amid these blurred lines, and with limited data on how well the tests perform when taken by people who do not have Covid symptoms, the MHRA is now reviewing its emergency approval of the Innova device.

The test’s EUA was granted on 23 December and is due to expire this month. In a letter sent from the MHRA to the DHSC, and seen by The Independent, the medicines regulator said the device will be “reviewed” if there “continues to be a need for a further authorisation”.

“A decision [will be] taken on whether it remains in the interests of the protection of health for a further authorisation or an amendment to this authorisation to be made,” the letter read.

An EUA provides short-term (typically six months) authorisation for a product while normal regulatory approval, such as a CE or UKCA marking, is pursued.

Under the initial approval granted in December, the MHRA said the emergency authorisation would come to an end on 22 June, or when the device is CE marked – meaning it meets EU standards for health products.

Graeme Tunbridge, MHRA director of devices, said the Innova test was not yet CE marked. He also confirmed to The Independent that the medicines regulator is “reviewing an application for the extension of an Exceptional Use Authorisation in relation to tests issued by NHS Test and Trace.”

While there are other CE marked self-tests available in the UK, these may not be aligned with the government’s specification for use in asymptomatic people as part of Test and Trace.

No 10 will be hoping that the regulator provides a green light for the continued use of the Innova devices after the US firm announced last week that a factory in Wales is soon set to begin producing millions of its tests a day.

Dan Elliott, chief executive of Innova, told the Financial Times the company was “making large investments into the UK”.

A number of manufacturers are used alongside Innova to provide the public with rapid lateral flow devices (LFDs) that can be used at home and which return a result in as little as 30 minutes.

People are encouraged to take two tests a week as part of the government’s plans to reopen society, alongside the vaccine programme.

However, scientists remain divided over the widespread use of LFDs, which are far less accurate than the laboratory-based PCR tests.

Analysis has shown the LFDs correctly identify, on average, 72 per cent of people who are infected with the virus and have symptoms. In those without symptoms, this figure drops to 58 per cent. But limited data makes it hard to draw firm conclusions, while accuracy varies between the different brands of LFDs.

Use of rapid tests in the UK has also dropped by 16.4 per cent over the past month, according to the latest Test and Trace data.

Between 15 April and 26 May, there has been a 951,174 fall in the weekly number of used lateral flow tests registered by members of the public – down from 5,772,872 to 4,821,698.

Those who test positive using a LFD are expected to confirm their result using the more accurate PCR test.

Dr Angela Raffle, a public health consultant at Bristol University, said it was “inevitable” that test fatigue is setting in. “Even in the first two weeks of school testing when infection rates were higher and people would have taken it more seriously, it took nearly 7,000 tests to find one positive,” she said.

“And many people are very busy with work, childcare, etc, and the time to perform a test and log the result is not insignificant.”

She was critical of the fact that the Innova test is still “being used as a 'test to enable' which is not what the special permission allows”.

A DHSC spokesperson said: “Around one in three people with Covid-19 experience no symptoms, so regular, rapid testing detects cases that wouldn’t have otherwise been found, breaking chains of transmission, including variants of concern.

“Testing is a vital tool as society reopens and anyone who uses an LFD test should report their result, whether it is positive or negative, within 24 hours on the gov.uk website.

“Every test used in the national testing programme has undergone rigorous clinical evaluation.”

Innova said it was unable to comment on its contract with the DHSC. It said its test is very good at picking up those who are most infectious and therefore tackling the spread of Covid.

Academic advocates say the tests are highly accurate, are fast to deliver results and serve as a vital public health component.